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Archive for the ‘Celgene’ Category

General news:

Approvals: Genzyme’s stem cell transplant drug Mozobil; Abbott‘s triglyceride drug TriLipix; Eisai‘s Lusedra for anesthesia.

Novartis‘ experimental MS drug (oral) looking really good compared to competition.

Wyeth and ghostwritten articles. This is going to be ugly – Wyeth paid a company to ghostwrite medical journal articles about its hormone therapy products and seek academic scientists to sign them as authors, a U.S. senator said. Documents from lawsuits suggest the drugmaker hired DesignWrite Inc. of Princeton, New Jersey, to draft manuscripts related to the Wyeth products and breast cancer risks, according to letters released today from Senator Charles Grassley of Iowa to the companies. Wyeth makes the hormone replacement drugs Prempro and Premarin…more

Roche CEO to other pharma/biotech companies: Let’s get gloomy.

More trouble for Elan/Biogen’s Tysabri – Yet again, the multiple-sclerosis medication has caused a serious brain infection, the same malady that prompted the drug to be withdrawn in 2005 for about a year. A German MS patient contracted PML, or progressive multifocal leukoencephalopthy, and remains hospitalized…more When you look at the numbers, however, it’s still a pretty small incidence. My question – if it weren’t an exotic brain infection, would this get so much press attention??

Would you like some Ritalin with that syllabus? – “We should welcome new methods of improving our brain function,” they write. “In a world in which human workspans and lifespans are increasing, cognitive enhancement tools – including the pharmacological – will be increasingly useful for improved quality of life and extended work productivity, as well as to stave off normal and pathological age-related cognitive declines. Safe and effective cognitive enhancers will benefit both the individual and society.” more

Newer antipsychotics: much ado about nothing? – The common distinction between first- and second-generation antipsychotics has no scientific basis and should be dropped, according to a paper in The Lancet. A meta-analysis of 150 double-blind studies found little evidence that newer, so-called atypical antipsychotics are more effective than older drugs for symptoms of schizophrenia, MedPage Today writes…more

Choose your friends wisely-and happily – Researchers looked at the social networks of more than 4,700 people whose happiness, along with other factors, had been tracked for 20 years. Those surrounded by cheery souls were more likely to have sunny dispositions, even if they didn’t known them…more

KV Pharma CEO: walked out or booted out? – This is one for the gossips. Marc Hermelin, the KV Pharmaceuticals ceo, is leaving under what could be politely called disputed circumstances. The drugmaker says he was fired, but Hermelin issued his own statement that he informed the board earlier this week that he is simply retiring, according to reports…more

J&J loses another Duragesic patch verdict, to the tune of $16.5M

Malaria vaccine one step closer – Two papers published in The New England Journal of Medicine are reporting the success of a pair of new vaccines tested in children in Africa. And experts say the results may open the door to sweeping trials of the vaccines in seven African nations by early 2009 and a completed formulation ready for approval by 2011. “We are,” Christian Loucq, director of the PATH Malaria Vaccine Initiative, tells Time, “one step closer to the day when malaria will join diseases like smallpox and polio.”  more

ImClone to cut field sales force by almost half, following acquisition by Eli Lilly.

Two blows to Avandia, one to Actos. Increased death risk: Avandia. Increased fracture risk among women: Both.

Using nicotine as a cure? Nope.

A summary of “where we’re at” with MS drugs, from PharmExec.com.

Fewer sales reps? Docs are OK with that. And here’s a 33-company list of where the jobs ain’t (recent layoffs). Ouch.

PhRMA’s beefed up drug advertising guidelines. As the pirate says, “these are more like guidelines…”

AstraZeneca‘s Symbicort cleared by FDA panel for asthma.

Top 50 Health 2.0 blogs.

Last week was ASH (American Society of Hematology) week, so we’ll feature a number of news items about blood diseases and treatments…

Encouraging blood platelet boost seen with Glaxo’s oral drug Promacta – Patients treated with GlaxoSmithKline PLC’s Promacta rather than a placebo were eight times more likely to have sustained increases in platelet counts, according to pivotal trial results announced by the company on Saturday…more

Zevalin – effective. You’ll have to flounder through all the technical terms to grasp the details!

Encouraging CLL treatment results with Celgene’s Revlimid in older patients.

Treanda may get to first-line treatment – Cephalon Inc’s Treanda was as effective in treating non-Hodgkin’s lymphoma as the standard chemotherapy regimen with far less toxicity, according to interim analysis of a late-stage study that could pave the way for the drug’s use as an initial treatment for the disease…more

Allos experimental drug for lymphoma shows strong results – Allos Therapeutics Inc said on Saturday a small, but potentially pivotal, trial of its experimental drug pralatrexate found it helped curb cancer in 27 percent of patients with an aggressive type of lymphoma…more

Efficacy of long-term treatment with Novartis’ Glivec/Gleevecawesome. And good stuff with Tasigna in CML patients also. Staying with Novartis, results reported for its oral iron-reducing drug Exjade.

Rituxan + chemo for leukemia: yep. – A combination of Genentech Inc’s cancer drug Rituxan and chemotherapy reduces by 41 percent the risk of death or cancer progression, compared with chemotherapy alone, for patients with a common form of leukemia, the company said on Saturday…more

The coming clot-busters.

On the breast cancer front:

Zometa: tumor shrinker – the osteoporosis drug zoledronic acid (Zometa) appears to shrink breast tumors in patients who undergo chemotherapy. The drug is already approved to treat breast cancer that has spread to the bone and, earlier this year, was reported to lower the risk of breast cancer recurrence in pre-menopausal women with early estrogen- or progesterone-positive tumors…more

Tykerb + Femara = survival benefit.

Hormone replacement pills: not good news – Taking the hormones for five years doubles the risk for breast cancer, according to a new analysis of the Women’s Health Initiative, a large federal study, revealing the most dramatic evidence yet of the dangers of the popular pills..more

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King begins hostile takeover proceedings with Alpharma – Brain Markison, King’s ceo, is disappointed that Dean Mitchell, Alpharma’s ceo, hasn’t responded to his initial offer $1.4 billion offer, which amounted to $33 a share. So Markison raised the bid to $37, or $1.6 billion, and is going directly to shareholders…more

J&J’s Christine Poon to retire.

ImClone to BMS: maybe we’re already dating – The drugmaker calls the $60-a-share bid by Bristol-Myers Squibb ‘inadequate,’ and goes on to say in a statement this morning that famed corporate raider Carl Icahn, who chairs ImClone’s board, has had ’several conversations with the ceo of a large pharmaceutical company,’ which was not named…more And more BMS-to-ImClone here, and on the response here.

Meanwhile, BMS grounding its fleet – Bristol-Myers Squibb is preparing to shut down its aviation operation at Trenton-Mercer Airport, sell four aircraft and dismiss about 32 employees as the drugmaker and leading Mercer County employer seeks to cut costs, according to sources familiar with the company’s plans…more

Amgen violating patents?

Can Botox relieve migraines?

FDA reports rare brain infection/death with Rituxan – The agency says a woman died of the rare viral infection more than a year and a half after discontinuing the drug, which is used to treat rheumatoid arthritis and non-Hodgkin’s lymphoma, and is marketed in the US by Genentech and Biogen Idec…more

Sanofi fills top job with Viehbacher from Glaxo – Chris Viehbacher, GlaxoSmithKline Plc’s head of North American operations, is to take a top job with French drugmaker Sanofi-Aventis, a person familiar with the situation said on Tuesday…more

Januvia, 2 years in: thumbs up – Merck & Co’s diabetes drug Januvia substantially improves blood sugar levels over two years of treatment when combined with the older drug metformin and is generally well tolerated, new data on Tuesday showed…more

Experimental diabetes drug (BMS/AZ) promising – Bristol-Myers Squibb and AstraZeneca’s experimental diabetes drug Onglyza significantly improves blood sugar control when added to older medicines, researchers said on Monday…more

Fast track for cancer drug Afinitor – An experimental drug from Swiss drugmaker Novartis AG has been granted priority review in the United States as a treatment for advanced kidney cancer. Novartis said on Tuesday that RAD001 or everolimus, which it plans to sell under the brand name Afinitor, had been accepted for fast review given the medicine’s potential to help patients who fail to respond to standard therapy…more

Tysabri for cancer? – Biogen Idec and Elan Corp have launched the first clinical trial of their multiple sclerosis drug Tysabri for patients with relapsed or refractory multiple myeloma, the companies said on Friday…more

Celgene gets a fast track for lung cancer drugCelgene Corporation (NASDAQ: CELG) today announced that Amrubicin has been granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer after first-line chemotherapy…more

Is Pfizer interested in Bayer?

Sample trouble: drives up costs? – Free drug samples provided by drugmakers to doctors could actually be costing uninsured patients more in the long run, according to a new retrospective study in the Southern Medical Journalmore

The Allergan-Medicis “death match” – Allergan and Medicis have been locked in a highly profitable death-match for several years, with both companies bringing out me-too versions of the others’ products, just like Coke and Pepsi…more

But will it be posted in the Post Office? The FDA 20The first list is a bare-bones compilation naming 20 medications and the potential issue for each. It provides no indication of how widespread or serious the problems might be, leading some consumer advocates to question its usefulness, and prompting industry worries that skittish patients might stop taking a useful medication if they see it listed…more

Zimmer growing some spine.

GSK and Valeant on epilepsy drug tie-up.

Pfizer and Medivation to work together on Alzheimer’s/Huntington’s treatment.

Genentech and Roche acting merged: facilities closing – The fallout from Roche’s looming acquisition of Genentech has started. Roche will close a research facility in Palo Alto, Calif., where a 1,000 people work, the San Jose Mercury News reports. Back in July Roche said it would pull the plug on the lab in Stanford Research Park, but the company hedged, saying the closure would happen if the bid for Genentech were successful. Genentech has demurred so far, but most people think it’s just a matter of time before the deal happens. And now, Roche told the Mercury News it’s closing the plant, no matter what…more

No vigil for Provigil at TakedaCephalon Inc. will end its co- promotion agreement with Takeda Pharmaceutical Co. in North America for the sleep-disorder drug Provigil, because net sales dropped to less than $850 million this year…more

UCB: Yep, we’re specialty now. Translation: downsizing – If you can’t buy a biopharmaceutical company, you might as well become one. UCB Pharma last week announced that it will trim 17 percent of its work force—about 2,000 employees—in order to reestablish the company as specialty drug firm….more

Every once in a while you want to visit here – Forbes’ New Drugs to Watch page.

This is way cool – A little-used cancer drug called bryostatin can repair brain tissue if it’s administered within 24 hours after a stroke, according to U.S. researchers. Current stroke treatments must be administered within three hours and aren’t able to repair damaged brain tissue, the scientists said…more

Shire and Vyvanse for ADHD – One of the recent unheralded successes of the drug world was Shire Pharmaceuticals‘ launch of Vyvanse, a new, long-acting treatment for attention deficit and hyperactivity disorder. The fact that so little attention has been paid to Vyvanse is a shame because the take-up of this drug has been impressive — it appears to be well on its way to supplanting Adderall XR as the king of the ADHD drugs…more

I kinda think this one’s a no-win for Genentech – Negative public opinion just keeps piling on to Genentech regarding its pricing policy on Lucentis and Avastin. This weekend saw a big Associated Press story describe how the company is refusing to ask the FDA to approve Avastin for use in treating “wet age-related macular degeneration,” an eye condition that leads to blindness. Genentech is doing this, most people believe, because Avastin would be a much cheaper treatment for wet AMD than Lucentis, another Genentech drug. It costs about $60 per dose to use Avastin on the disease, and $2,000 to use Lucentis…more

Speaking of no-win – releasing Vytorin data…more

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There’s a ton of stuff going on this week, plus we’re in pre-ASCO mode (so lots of oncology news – scroll down for those headlines). Here we go:

What’s a vaptan? Maybe something pretty exciting – A new class of drugs called vaptans may be able to treat a wide variety of conditions including painful periods, brain hemorrhage, psychotic disorders and glaucoma, Belgian researchers report…more

One less tree in that Forest – Forest Laboratories Inc has ended its agreement with Daiichi Sankyo Co Ltd to co-promote Daiichi’s blood-pressure drug Azor, as Forest shifts resources to support other products, the companies said on Monday…more

Viagra: good for MD? – Researchers found the way the drug works to combat impotence may also help ward off heart failure in muscular dystrophy patients…more

OK, it’s not pharma per se, but it’s way too cool: Nanohealing – A startup based in Cambridge, MA, says that it plans to soon begin clinical trials of a nanostructured material that stops bleeding almost instantly…more

Here’s a switch: the FDA downgrading a warning – The FDA has eased restrictions on drugs used to enhance ultrasound images of the heart…more

Abbott’s new stent looking very good: interesting backstory – Abbott said this morning that its Xience stent outperformed Boston Scientific’s Taxus on several measures in a two-year study. The results mean the stent is likely to get the green light from the FDA soon…more

Merck and Ranbaxy: let’s develop something together – Merck signed a deal on Monday with Indian generics giant Ranbaxy to codevelop a new line of anti-infectives. As part of the agreement, Ranbaxy stands to receive more than $100 million for each drug that passes a certain milestone. That’s on top of an undisclosed upfront payment…more

Takeda’s financial results hiccup: no surprise when you’re buying another company!Japan’s largest drug manufacturer, Takeda Pharmaceutical, reported on Friday its first operating profit decline in 16 years and warned that the net profit in fiscal 2009 would diminish by more than a half as a result of its recent $8.8 billion deal to buy Millennium Pharmaceuticals in the United States…more

Daiichi Sankyo: the ups and downs of growth – Daiichi Sankyo Co., Japan’s third- largest drugmaker, had a 44 percent jump in quarterly net income, led by higher sales of its blood pressure treatments. The company predicts profit will drop this year…more

Trasylol bows out – Bayer AG is removing remaining supplies of its heart-surgery drug Trasylol from the U.S. market after a long-awaited study found it raised the risk of death compared to two alternatives, U.S. regulators said on Wednesday…more

Diabetes beating cholesterol on spending – Diabetes treatments are now the leading driver of prescription drug spending growth, displacing lipid-lowering drugs which fell precipitously after a decade of reigning in the top position, as generic drugs cut the cost of treating high cholesterol…more

The heartbreak of psoriasis to be lessened soon? – A top Johnson & Johnson research official said on Wednesday the company’s experimental drug ustekinumab could become the “gold standard” for treating psoriasis, in part because it would require only four injections a year…more

J&J gets crossed off in court – Remember that truth-is-stranger-than-fiction drama that featured Johnson & Johnson suing the American Red Cross over the use of the red cross logo? Turns out it’s not going so well for J&J. A judge today threw out most of what was left of the case, the Associated Press reportsmore

On the Oncology/pre-ASCO front:

Cancer drugs: the big growth area? – Sales of cancer drugs will grow at nearly double the rate of the global pharmaceutical market and could reach $80 billion by 2012, according to IMS Health, which tracks prescription drug sales…more

Can cancer cure Pfizer?

Novartis’ experimental RAD001 making strides with kidney cancer – Nearly two-thirds of kidney cancer patients taking Novartis AG’s RAD001 had progression of their disease delayed by a year, a significantly better result than in those taking placebo, investigators said…more

Novartis’ Zometa may slow cancer progression: A drug prescribed to prevent fractures in breast cancer patients whose tumors have spread may actually help slow the cancer itself, U.S. researchers reported on Thursday…more

Pharmalot has links to some other early ASCO news, including Avastin, Herceptin, Vectibix, Denosumab, and Alimta.

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Ahhh, red wine. You just knew it was medicinal, right? Here’s further proof!

Could this be a game-changer? I love studies like this! Alzheimer’s symptoms reduced within minutes…you’ll never guess how.

Another health system bans drug rep trinkets. I like tchotchkes, however, so if you have extras, please forward them along.

Celgene revs it up. Bad pun, I know.

We’ve got a me-too! And that warrants a press release! (Pegintron / Pegasys)

More evidence of a virus causing cancer.

The ads ought to be interesting, but hopefully they don’t have one lined up for the Super Bowl (“When we get ready for the Big Game, I wish we could have one-a-day pills instead of twice-a-day practices. Now you can etc…”). Once-a-day Cialis approved.

Big Pharma taking a beating in the public eye – so, is the industry a boxer, or a little traveler surrounded by wolves? John Mack faces off – well, at least on graphics – with Pharmaceutical Executive.

Breaking news: J&J gets clearance for new HIV drug.

Breaking news: Novartis gets clearance for Tekturna HCT (Tekturna plus diuretic for HBP)

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Some interesting oncology results:

Millennium‘s Velcade used in combo therapy for multiple myeloma shows impressive results.

Cephalon‘s Treanda shows impressive remission numbers for CLL, and effectiveness in non-Hodgins lymphoma (NHL).

Celgene‘s Revlimid continues to produce good results at a low-dose regimen.

Novartis‘ Gleevec: effective at halting leukemia progression up to 6 years.

Eisai decides to grab MGI Pharma, and its stable of oncology drugs.

Biogen-Idec‘s Zevalin, a radioimmunotherapy agent, halted NHL progression in 76% of patients (single treatment!).

AZ’s Arimidex shown superior to tamoxifen for breast cancer, even 4 years after treatment.

GSK‘s Tykerb helps fight brain tumors in combo with Xeloda.

And, on the bleeding edge:

Prasugrel (new blood thinning treatment from Daiichi-Sankyo and Lilly) continues to show promise – and some mixed results in certain populations.

Glaxo‘s experimental platelet booster shows efficacy in long-term treatment (Glaxo also announced new deals with 2 biotechs). However, GSK is now hit with a delay on its Cervarix vaccine.

Bayer and J&J’s experimental blood thinner takes on market-leader Lovenox in blood clot prevention study.

WSJ has summary article on the blood thinner race to market.

And, in other news:

Novartis the latest to announce major job cuts.

Merck still developing obesity and cholesterol drugs.

FDA approves new blood pressure drug from Mylan/Forest.

Lilly CEO to retire.

Changing endpoints…a clinical study no-no. WSJ has the story, on a long-delayed Vytorin study.

Is Alzheimer’s a form of diabetes? Very intriguing line of research…

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Glaxo buying Reliant – GlaxoSmithKline Plc has agreed to buy privately held heart drug specialist Reliant Pharmaceuticals for $1.65 billion in cash, in a move to boost its flagging drug sales in the United States…more

J&J says good-bye to $440 mil – Johnson & Johnson said on Thursday its fourth-quarter results would include a special after-tax, noncash charge of $440 million from a write-down related to a decline in sales of acute heart failure drug Natrecor…more

Fountain of youth? – Scientists at Sirtris Pharmaceuticals Inc. say they have created a drug that mimics the ingredient in red wine linked to longevity and the cell structures that power endurance athletes like cycling champion Lance Armstrong. The new molecule is 1,000 times more potent than the wine derivative, resveratrol, and could lead to solutions for diseases of aging, including cancer and diabetes, according to authors of a study in today’s issue of the journal Nature…more

Abbott‘s Xience stent showing good side effect profile and efficacy…gets FDA panel green light – Abbott Laboratories Inc  won a U.S. advisory panel’s support on Thursday for an experimental drug-coated stent for heart patients. A committee of advisers to the Food and Drug Administration voted 9-1 to recommend approval of the device, called Xience. The FDA usually follows panel recommendations…more

On the Oncology front…

Novartis gets EU approval for Tasigna – Novartis AG (NVS) Wednesday said that Tasigna, a potential follow-up to Gleevec, the Swiss drugmaker’s second best-selling drug, won European Union approval for the treatment of a certain form of leukemia. Novartis, based in Basel, said Tasigna is a new targeted cancer drug for patients with a form of the life-threatening blood cancer chronic myeloid leukemia, who are resistant or intolerant to treatment with Gleevec. Novartis expects Tasigna to eventually replace Gleevec and plans to test its efficacy and safety in patients who haven’t yet been treated with Gleevec…more

Celgene‘s Revlimid combined with dexamethasone effective for multiple myeloma – A combination drug regimen that includes a derivative of thalidomide extended survival, as well as the time it took for the disease to reappear, in patients with multiple myeloma…more

Freeze tumors, reduce pain – Freezing tumors may help relieve the extreme pain of cancer that has spread to the bone, which is often untouched by narcotics or radiation, U.S. researchers said on Tuesday. This freezing process, called cryoablation, is often used to destroy kidney, prostate and other tumors, but researchers at the Mayo Clinic in Rochester, Minnesota, found it eased cancer pain in 80 percent of patients in a small study, and the effect lasted for up to six months…more

It’s not drugs, but it’s fascinating – Vivek Rangnekar, a University of Kentucky College of Medicine professor of radiation medicine and a team of researchers say they have found a tumor-suppressor gene called “Par-4” in the prostate. The researchers discovered that the Par-4 gene kills cancer cells, even highly aggressive types, but not normal cells, according to a study published in the journal Cancer Research and funded by grants from the National Institutes of Health. Rangnekar’s study found that mice born with this gene do not develop tumors. They grow normally, have no defects and actually live a few months longer than the control animals…more

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Looks, on the surface, like a good match of products and market presence – Celgene buys Pharmion. And, in other important oncology news, Nexavar (from Bayer) gets expedited approval for liver cancer.

Also, Schering cleared to take over Organon – by divesting bird vaccines to Wyeth.

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